HQ 952893: Decision of Application for Further Review of Protest No. 1704-92-100327, on the Classification of Viaspan.

Native CBP ruling rendition. Applicability is fact-specific; modification/revocation relationships and original publisher date are retained. Publisher sentinel year0001 means unknown date, not a historical legal adoption.

                                HQ 952893

                              September 15,1993


CLA-2 CO:R:C:F  952893 JGH

CATEGORY:  Classification

TARIFF NO.: 3823.90.5050

District Director of Customs
1 East Bay Street
Savannah, Georgia  31401

RE:  Decision of Application for Further Review of Protest No.
     1704-92-100327, on the Classification of Viaspan.

Dear Sir:

     This protest involves the classification under the
Harmonized Tariff Schedule of the United States (HTSUS), of
Viaspan imported by Dupont Merck from the Netherlands, in April
1992.

FACTS:

     Viaspan is described as a sterile, nonpyrogenic solution
used for hypothermic flushing and preserving of human organs,
such as, kidneys, livers or pancreas prior to transportation. 
The composition is given as:

                                     Composition
          Ingredient               (grams per liter)

      etherified starch                   50.0
      lactobionic acid                    35.8
      potassium phosphate monobasic        3.4
      magnesium sulfate heptahydrate       1.2
      raffinose pentahydrate              17.83
      glutathione                          0.9
      allopurinol                          0.1
      adenosine                            1.3
      potassium hydroxide                  q.s.
      sodium hydroxide                     adjust pH
      water                                q.s.

     Viaspan was entered under the provision for other modified
starches in subheading 3505.10.00, HTSUS.  However, Customs
liquidated the entries under the provision for other medicaments
in subheading 3004.90.60, HTSUS. - 2 -

ISSUE: 

     Whether Viaspan is classifiable as an modified starch in
subheading 3505.10.000, HTSUS, or a mixture in subheading
3823.90.5050, HTSUS.

LAW AND ANALYSIS:

     It is now acknowledged that since Viaspan is not used for
therapeutic purposes, it is not classifiable as medicament in
heading 3004, HTSUS.  In fact, in September 1992, Customs issued
a decision classifying Viaspan as a mixture in 3823.90.5050.
(NYRL 877022)

     In behalf of the importer it is claimed that Viaspan is
classifiable as a modified starch, since this is its largest
component and gives the product its essential character.  General
Rule of Interpretation 3(b), HTSUS.  A statement from a research
director of Dupont Merck is to the effect that Viaspan's purpose
is to prevent destruction of the cells of the organs once they
are out of the body, and that the modified starch is the only
active ingredient; all of the "other constituents are considered
inactive ingredients."  While Viaspan is admitted not to be a 100
percent etherified starch, it is the largest component; the one, 
it is claimed, which performs the organ preservation function of
the solution.

     If, in fact, the above claims were true, there might be some
merit to the argument that classification should be based on the
product's essential character.  However, it is believed that all
of the components play a role in the solution's preservative
function - the etherified starch is an element in controlling the
osmotic cellular pressure; the monobasic potassium phosphate,
magnesium sulphate heptahydrate, potassium hydroxide and sodium
hydroxide all help to maintain the proper ph environment so that
the organ will remain viable ex vivo; allopurinol is an oxidase
inhibitor which decreases cell waste production and the raffinose
pentahydrate provides readily available nourishment to the cells. 
Thus, it is the combination of all the components of the mixture
which give Viaspan its preservation qualities.

HOLDING:

     Viaspan is classifiable under the provision for other
chemical products and preparations of the chemical or allied
industries (including those consisting of mixtures of natural
products), not elsewhere specified or included, in subheading
3823.90.5050, HTSUS.          - 3 -

     The protest is denied, except to the extent that the
reclassification as indicated above results in a partial
allowance.

     A copy of this decision should be attached to the From 19
Notice of Action sent to the protestant.

                              Sincerely,




                              John Durant, Director